Recruiting
Phase 2
Phase 3

Amniotic Membrane Therapy

Sponsor:

David Sheyn

Code:

NCT06096597

Conditions

Interstitial Cystitis

Painful Bladder Syndrome

Painful Bladder Syndrome (PBS)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Clarix Flo

Placebo

Study Details

Brief summary:

Interstitial cystitis/painful bladder syndrome (IC/PBS) is a clinical syndrome in which patients report symptoms of bladder and/or pelvic pain with pressure and/ or discomfort associated with urinary frequency and urgency.

The primary objective of this study is to determine the efficacy of amniotic membrane therapy in patients with interstitial cystitis/painful bladder syndrome (IC/PBS) as defined by clinically-significant improvement in validated symptom questionnaires.

Conditions

Interstitial Cystitis

Painful Bladder Syndrome

Painful Bladder Syndrome (PBS)

Study ID

NCT06096597

Start date

Jul 24, 2024

Status verified date

Sep, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Patients 18 years of age or older
  • Female
  • English Speaking
  • Diagnosis of IC/PBS
  • Have failed at least one prior treatment for IC/PBS

Exclusion Criteria:

  • Patients less than 18 years of age
  • Unable to provide consent
  • Non-English speaking
  • Patients with known anatomical malformations of the ureters, bladder, or urethra

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Amniotic Membrane Therapy

Under general anesthesia, cystoscopy will be performed. A needle will be inserted into the detrusor muscle to a depth of approximately 2 mm. 100mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride, and 0.5 mL of the solution will be injected into 20 equally spaced sites into the posterior and lateral walls of the bladder, sparing the dome and the trigone.

placebo comparator: Placebo

Under general anesthesia, cystoscopy will be performed. A needle will be inserted into the detrusor muscle to a depth of approximately 2 mm. 0.5 mL of 10 mL of 0.9% preservative-free sodium chloride will be injected into 20 equally spaced sites into the posterior and lateral walls of the bladder, sparing the dome and the trigone.

Interventions

Clarix Flo

100 mg of commercially available micronized amniotic membrane (Clarix Flo; BioTissue, Miami, FL) diluted in 10 mL of 0.9% preservative-free sodium chloride

Placebo

10 mL of 0.9% preservative-free sodium chloride

Primary outcome measure

  • Change in Interstitial Cystitis Symptom Index (ICSI) score [ Time Frame: To be completed pre-operatively and at 2, 4, 8 and 12 weeks post-operatively ]

Central Contacts and Locations

Central contacts

Diana Mitchell, MD

(216) 844-3009diana.mitchell@uhhospitals.org

David Sheyn, MD

David.Sheyn@uhhospitals.org

Locations

University Hospitals

Recruiting

Clevleand, Ohio, United States, 44106

Contacts

Diana Mitchell, MD

(216) 844-3009diana.mitchell@uhhospital.org

More Information

Sponsor

David Sheyn

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • interstitial cystitis
  • painful bladder syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Sheyn on 2026-09-04.